O4 Research managed a Phase III paediatric vaccine study in 3 and 4-year old healthy children. A thorough site feasibility and selection process was completed to ensure investigative sites had adequate resources required to deliver within target.
We at O4 understand the enrolment challenges faced in paediatric studies and the need for recruitment initiatives that resonate with both children and their parents/guardians. These initiatives which incorporated therapeutic awareness and education in the community ultimately assisted site staff in approaching families regarding study participation and led to enhanced recruitment.
A competitive recruitment strategy was planned between O4 and investigative sites from the outset and mitigation strategies were put in place for any potential barriers that were identified.
Although a delay in vaccine supply impacted recruitment, O4 was proactive in meeting recruitment targets, and ultimately study wide success was achieved in a reduced study timeline.